Zeller Thomas, Tiefenbacher Christiane, Steinkamp Hermann J, Langhoff Ralf, Wittenberg Günther, Schlüter Michael, Buergelin Karlheinz, Rastan Aljoscha, Krumsdorf Ulrike, Sixt Sebastian, Schulte Carl-Ludwig, Tübler Thilo, Krankenberg Hans
Department of Angiology, Herz-Zentrum Bad Krozingen, Germany.
J Endovasc Ther. 2008 Aug;15(4):390-8. doi: 10.1583/08-2461.1.
To investigate the impact of nitinol stenting of superficial femoral artery (SFA) lesions with a maximum length of 10 cm (TASC-II A or B) on 1-year outcomes compared to a historical study cohort from the Femoral Artery Stent Trial (FAST).
Between January 2004 and August 2005, 6 study sites enrolled 110 symptomatic patients (75 men; mean age 68+/-9 years) with a single de novo >70% SFA lesion <10 cm long treated with the self-expanding nitinol Conformexx stent. The primary study endpoint was binary restenosis determined by duplex ultrasound at 12 months. Secondary 12-month endpoints were target lesion revascularization (TLR), ankle-brachial index (ABI), mean Rutherford category, >1-class change in Rutherford category, and major adverse events. Data were analyzed according to the intention-to-treat principle and according to the actual treatment received ("on treatment" analysis). Outcomes were compared to the historical balloon angioplasty (BA) arm and the Luminexx 3 stent arm of the randomized FAST study.
Technical success was achieved in 106 (96%) patients; at 1 year, the primary endpoint of ultrasound-assessed binary restenosis was reached in 14 (23.3%) of 60 patients (95% CI 13.4% to 36%). This restenosis rate was lower versus the historical BA (38.6%, p=0.057) or Luminexx 3 stent controls (31.7%, p=0.284) from FAST. The clinically driven TLR was 7.4% (7 of 94 clinically controlled patients), which was also lower compared to 18.3% (p=0.098) and 14.9% (p=0.267) for the historical BA and Luminexx 3 stent groups, respectively. The mean Rutherford category was reduced from 2.75+/-0.79 to 0.94+/-1.38 (p<0.0001); 85.1% were improved by at least 1 Rutherford category. The ABI increased from 0.62+/-0.15 to 0.85+/-0.20 (p<0.0001).
This study of patients with SFA lesions documented favorable outcomes using nitinol stents in TASC-II A or B lesions after 1 year. The study was underpowered to prove superiority of the Conformexx nitinol stent design compared to historical balloon only or Luminexx 3 stent groups.
与股动脉支架试验（FAST）的历史研究队列相比，探讨对最大长度为10厘米的股浅动脉（SFA）病变（TASC-II A或B型）进行镍钛合金支架置入术对1年预后的影响。
2004年1月至2005年8月期间，6个研究地点纳入了110例有症状的患者（75例男性；平均年龄68±9岁），这些患者有单一新发的、长度小于10厘米且狭窄程度>70%的SFA病变，采用自膨式镍钛合金Conformexx支架进行治疗。主要研究终点是12个月时通过双功超声测定的二元再狭窄。12个月的次要终点是靶病变血运重建（TLR）、踝肱指数（ABI）、平均卢瑟福分级、卢瑟福分级变化>1级以及主要不良事件。数据根据意向性治疗原则并根据实际接受的治疗（“治疗中”分析）进行分析。将结果与随机FAST研究的历史球囊血管成形术（BA）组和Luminexx 3支架组进行比较。
106例（96%）患者获得技术成功；1年时，60例患者中有14例（23.3%）达到超声评估的二元再狭窄主要终点（95%可信区间13.4%至36%）。与FAST的历史BA组（38.6%，p = 0.057）或Luminexx 3支架对照组（31.7%，p = 0.284）相比，该再狭窄率较低。临床驱动的TLR为7.4%（94例临床对照患者中的7例），与历史BA组的18.3%（p = 0.098）和Luminexx 3支架组的14.9%（p = 0.267）相比也较低。平均卢瑟福分级从2.75±0.79降至0.94±1.38（p<0.0001）；85.1%的患者卢瑟福分级至少改善了1级。ABI从0.62±0.15增加到0.85±0.20（p<0.0001）。
这项对SFA病变患者的研究记录了在TASC-II A或B型病变中使用镍钛合金支架1年后的良好预后。该研究的样本量不足以证明Conformexx镍钛合金支架设计优于仅使用历史球囊或Luminexx 3支架组。
Zotero 插件